Patient-focused Approaches to Rigorous Clinical Research (PARCR) Training Project

The Patient-focused Approaches to Rigorous Clinical Research (PARCR) Training Project is designed to help users better understand and apply the recommendations outlined in the FDA’s Patient-Focused Drug Development (PFDD) series. The PFDD guidance series was developed to help stakeholders collect and submit patient experience data, as well as other relevant input from patients and caregivers, to support medical product development and regulatory decision‑making. These documents outline a step-by-step approach to integrating the patient voice into the development process.

Whether you are part of a regulated industry, an academic research team, or a patient-powered research group, this training offers practical insights to support your work in patient-centered outcomes research.

This project is being developed by an interdisciplinary team that includes Duke University, Triangle CERSI, Symphony Learning, and Vector Psychometric Group, with collaboration and funding support from the U.S. Food and Drug Administration (FDA).

The PARCR Training Project is guided by an external advisory panel composed of experts from diverse backgrounds and experiences.

👉 To learn more about the project team, please visit the Project Team section of the website.

👉 To learn more about our advisory panel members and their contributions, please visit the Advisory Board section of the website.

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award Center of Excellence in Regulatory Science & Innovation, U01FD007857 totaling $2,033,969 from CDER PFDD. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Stay Connected with PARCR

Want to receive updates about new modules and announcements from the PARCR training series

Fill out our brief interest form 

Or reach out to us directly at PARCR@duke.edu — we’d love to hear from you!